Real Life Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer in the Middle Eastern Countries (REALME)
Advanced NSCLC remains largely fatal, with the positive impact of chemotherapy limited by
intrinsic and acquired resistance, manifested clinically by early progression and transient
responses. Current chemotherapy regimens have limited efficacy with a magnitude of survival
benefit that is still modest, and lead to significant toxicity, with many patients unable to
receive this kind of treatment, even in first line setting. There is, therefore, a great
need to provide patients with less toxic agents such as the novel targeted therapies, with
the potential to improve the efficacy and maintain a good quality of life with little
associated toxicity. TarcevaTM has shown benefit as single agent in pretreated patients who
have progressed despite platinum-based chemotherapy as summarized in section 1.2 with
minimal toxicity compared to chemotherapy, and also is currently assessed as first line
treatment in advanced NSCLC with promising preliminary efficacy results.
As previously described, TarcevaTM has recently been shown to prolong survival in a large,
randomized, placebo-controlled Phase III trial including 731 NSCLC patients no longer
candidates for further chemotherapy. This is the first and so far the only evidence of
definitive clinical benefit provided by an EGFR inhibitor in cancer patients. TarcevaTM is
the standard of care for second and third line treatment for lung cancer in USA and Europe.
However, the experience with this agent in the Middle Eastern population is very limited.
The rationale for this program is to evaluate the pattern of TarcevaTM use in patients with
advanced (inoperable stage III or IV) NSCLC who have failed standard treatment, or patients
who can not receive other systemic anticancer therapy, or patients who are not medically
suitable for chemotherapy (e.g., poor performance status). This will also enable us to study
the efficacy and safety of TarcevaTM in this population, as there may be differences in the
pharmacogenomic of this population and the previously studied population.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the pattern of use of TarcevaTM in Middle Eastern patients with advanced NSCLC
Abdulrahman Jazieh, MD/MPH
King Abdul Aziz Medical City for National Guard
Saudi Arabia: King Abdullah International Medical Research Center